Medicinal Product Support in Vietnam End-to-End Medicinal Product Regulatory Support in Vietnam 

Medicinal Products Regulatory Support in Vietnam – Overview

Vietnam’s pharmaceutical sector is rapidly evolving into one of the most attractive markets in Southeast Asia. The market continues to grow at a steady pace, driven by expanding healthcare coverage, increased government investment in the health system, and rising consumer demand for quality and affordable medicines. The government’s focus on Regulatory harmonization with ASEAN and ICH standards, coupled with incentives for technology transfer and local manufacturing, is making Vietnam a preferred destination for global pharmaceutical manufacturers seeking long-term, compliant market access.

Medicinal Product Classification in Vietnam

According to Circular No. 20/2017/TT-BYT, Vietnam’s Ministry of Health (MOH) classifies drugs into specific legal categories to ensure safe and rational use.

1. Over-the-Counter (OTC) Drugs
These are medicines deemed safe for self-medication without a physician’s prescription. They are typically used for common, minor ailments such as headaches, colds, or mild pain and are considered low-risk when used as directed.

2. Prescription Drugs
Prescription-only medicines require a valid prescription from a licensed healthcare professional. These products may have potential side effects, interactions, or contraindications that necessitate medical supervision to ensure appropriate and safe use.

3. Traditional Herbal Medicines
Medicines derived from natural plant sources used in traditional or ethnomedicine practices. Certain traditional herbal preparations with therapeutic claims are regulated as pharmaceutical products under MOH oversight.

4. Controlled Drugs
These substances are subject to stringent regulatory control due to their potential for dependence, abuse, or serious adverse effects. Their manufacture, distribution, prescription, and use are closely monitored by regulatory authorities under special provisions.

Types of Controlled Drugs (as per Article 3, Circular 20/2017/TT-BYT)

• Narcotic Drugs: Contain narcotic active ingredients or a combination of narcotic and psychotropic substances.
• Psychotropic Drugs: Contain one or more psychotropic active ingredients or combinations with precursors.
• Precursor Drugs: Contain substances used in the synthesis of narcotic or psychotropic drugs.
• Combined Drugs: Include both narcotic and psychotropic active ingredients, regardless of precursor content.

All regulated substances and their concentration limits are listed in Appendices I–VI of Article 3 of Circular 20/2017/TT-BYT.

Medicinal Product Drug Registration & Approval

Drug Administration of Vietnam (DAV) under the Ministry of Health (MOH) oversees the registration, licensing, and post-marketing surveillance of all pharmaceutical products.

Applicable Regulations:

• Circular 12/2025/TT-BYT – Governs marketing authorization of drugs and medicinal materials.
• Circular 30/2025/TT-BYT – Defines standards for drug quality, testing, and recall.
• Decree 163/2025/ND-CP – Specifies limits and procedures for drug registration and marketing authorizations.

Registration Process Overview:

1. Determine Product Classification
   Products are classified as chemical drugs, biologicals, vaccines, herbal/traditional medicines, or biosimilars. Classification impacts dossier requirements and review timelines.
2. Appoint a Local Marketing Authorization Holder (MAH)
   Foreign manufacturers must appoint a Vietnam-based MAH or local representative to liaise with DAV, submit dossiers, and manage post-approval activities.
3. Prepare and Submit the Dossier
   Dossiers must follow the ASEAN Common Technical Dossier (ACTD) or ICH-CTD format and include:
   • Administrative/legal documents (CPP, GMP certificate, product license)
   • Quality (CMC) data
   • Non-clinical and clinical evidence
   • Labeling, packaging, and pharmacovigilance plans

Submission is made through the DAV online portal or physically, as per Circular 12/2025.

4. Evaluation & Review
   DAV performs scientific and quality evaluations, supported by expert committees. Queries may be raised during review, with limited rounds of clarification allowed.
5. Marketing Authorization (MA) Grant
   Once approved, the MA certificate is valid for five (5) years and renewable upon submission of updated documentation and compliance evidence.
   For new drugs, vaccines, or biologicals under enhanced monitoring, validity may initially be three (3) years.
6. Renewal & Post-Approval Changes
   Renewals and variations (site, formulation, labeling) follow defined procedures under Circular 12/2025.
   Significant changes require prior DAV approval.
7. Pharmacovigilance & Lifecycle Management
   MAHs must maintain pharmacovigilance systems, report adverse events, ensure product recalls when necessary, and comply with post-marketing surveillance obligations.

Typical Review Timeline

• 12–18 months (standard review)
• Fees depend on product category and dossier complexity; details are available in the DAV’s annual fee schedule.

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